MedPath

Dexmedetomidine in Serratus Plane Block for Mastectomy

Not Applicable
Completed
Conditions
Postoperative Pain
Interventions
Drug: General anesthesia
Drug: Bupivacaine-Dexmedetomidine
Registration Number
NCT03498092
Lead Sponsor
Alaa Mazy
Brief Summary

The serratus plane block (SPB) described by Blanco et al, 2013 is a progression from the work with the Pecs I and II blocks. The serratus muscle is a superficial and easily identified muscle and considered a true landmark to perform thoracic wall blocks because lateral cutaneous branches of the intercostal nerves pierce it in the mid-axillary line. A local anesthetic (LA) is injected under ultrasound (US) guidance either superficial or deep to serratus anterior muscle providing predictable and relatively long-lasting regional anesthesia, which would be suitable for surgical procedures performed on the chest wall.

The linear US probe of frequency (6-13 MHz) is placed over the mid-clavicular region in a sagittal plane.The ribs are counted inferiorly and laterally until the fifth rib in the midaxillary line is identified.The latissimus dorsi, teres major, and serratus muscles are identified.

Detailed Description

Possible regional techniques for breast surgery include selective intercostal nerve blockade, thoracic paravertebral blockade, thoracic epidural, intrapleural, local wound infiltration. Each of these techniques has advantages and disadvantages. In general, local or wound infiltration is safe but limited in terms of duration of action, depending on the local anesthetic (LA) used. More invasive techniques such as selective intercostal nerve blocks and thoracic paravertebral blockade may be complicated by pneumothorax or transient Horner's syndrome These techniques are also may be associated with higher risk of local anesthetic toxicity. Besides the neurological side-effects associated with thoracic epidural and paravertebral blocks such as post-sympathectomy hypotension and bradycardia, total spinal block, paraplegia, epidural hematoma, unpredictable spread, intravascular injection also requires special skill precluding their routine use in the setting of day-case surgery. With the use of ultrasound (US) devices in anesthetic practice, newer regional techniques based on detailed knowledge of innervations of the breast are developed as the pectoral nerve (Pecs) block I and II.The breast innervations briefly include lateral and medial pectoral nerves that arise from the brachial plexus innervating the pectoral muscles.The anterior divisions of the thoracic intercostal nerves from T2 to T6. They give off lateral and anterior branches. The Lateral branches pierce the external intercostalis and the serratus anterior muscles at the mid-axillary line to give off anterior and posterior terminal cutaneous branches. The lateral cutaneous branch of the second intercostal nerve does not divide and it is called the intercostobrachial nerve.The Anterior branches pierce the internal intercostalis muscle, the intercostal membranes, and pectoralis major to supply the breast in its medial aspect.The long thoracic nerve passes on the serratus anterior muscle supplying it. The thoracodorsal nerve innervates the latissimus dorsi muscle.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
150
Inclusion Criteria
  1. Patients of American Society of Anesthesiologists (ASA) grade I - III.
  2. Scheduled for unilateral modified radical mastectomy.
Exclusion Criteria
  1. Patient with the skin infection in the axilla.
  2. Allergy to local anesthetics of the amide type.
  3. Patient refusal.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Saline groupGeneral anesthesiaThis group will serve as a control and blinding group and will receive saline infiltration in the same manner.
Bupivacaine groupBupivacaineAfter general anesthesia, patients will receive a cocktail of isobaric bupivacaine 2.5 mg/ml plus 5 micrograms (mcg)/ml adrenaline in a volume of 0.5 ml/kg injected superficial to serratus muscle between and below latissimus dorsi muscle.
Bupivacaine-Dexmedetomidine groupBupivacaine-DexmedetomidineAfter general anesthesia, patients will receive a cocktail of isobaric bupivacaine 2.5 mg/ml plus 5 micrograms (mcg)/ml adrenaline and 1mcg/kg dexmedetomidine in a volume of 0.5 ml/kg injected superficial to serratus muscle between and below latissimus dorsi muscle.
Primary Outcome Measures
NameTimeMethod
The time of the first analgesia request24 hours postoperative

minutes

Secondary Outcome Measures
NameTimeMethod
The total analgesic requirements (Ketorolac)24 hours postoperative

milligram

Mean arterial blood pressureintraoperative every 30 minutes, and postoperative at 2, 4, 6, 10, 16, 24 hours

millimeter mercury

Sedation assessed by the observer's assessment of alertness & sedation scorepostoperative:10, 20, 30 minutes after extubation

sedation score (1-5):

5 = patient respond to name spoken in normal voice.

4 = patient asleep but arousable to normal tone voice.

3 = patient asleep but arousable to loud voice.

2 = patient asleep but arousable by mild prodding or shaking.

1 = comatose.

The Incidence of postoperative nausea and vomitingpostoperative for 24 hours

percent

Pain assessed by Visual Analogue ScalePostoperative: immediately after surgery, 2, 4, 6,10, 16, 24 hours postoperative

Visual Analogue Scale: between 0 and 10 (0 representing no pain and 10 is the worst imaginable pain)

Heat rateintraoperative every 30 minutes, and postoperative at 2, 4, 6, 10, 16, 24 hours

Beat per minute

Patient satisfaction assessed by a visual analogue scorepostoperative 24 hours after surgery

A score (0-10): 0 is the least satisfaction,10 the maximum satisfaction.

Amount of fentanyl consumptionIntraoperative.

microgram

Trial Locations

Locations (1)

Oncology Center Mansoura University.

🇪🇬

Mansourah, DKH, Egypt

© Copyright 2025. All Rights Reserved by MedPath